Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris

A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Dapsone; Tretinoin; Drug: Tretinoin

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Strongsville, Ohio, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Facial acne vulgaris characterized by the following:

  • 30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;
  • Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)
• Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

Exclusion Criteria:

• Non-compliance with washout period;
• History of clinically significant anemia or hemolysis;
• Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
• Allergy or sensitivity to any component of the test medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; Dapsone gel 5% and Tretinoin gel 0.025%	Drug: Dapsone; Tretinoin; Dapsone topical gel 5%, 1 pea-size amount BID x 12 weeks and Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks; Other Names: Aczone Gel 5%; Tretin-X Gel 0.025%
ACTIVE_COMPARATOR: 2; Tretinoin gel 0.025%	Drug: Tretinoin; Tretinoin gel 0.025%, 1 pea-size amount QD x 12 weeks; Other Names: Tretin-X Gel 0.025%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Inflammatory Lesion Counts (Papules, Pustules and Nodules) at Week 12	Change from baseline in inflammatory lesion counts (papules, pustules and nodules) at week 12. Papules and nodules are round, solid elevations of the skin with no visible fluid; papules are smaller (less than 5 or 10 millimeters in width and depth) and nodules are larger (greater than 5 or 10 millimeters in width and depth). Pustules are small elevations of the skin containing cloudy material. A negative number change from baseline indicates a reduction in lesion counts (improvement).	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Investigator Global Assessment at Week 12	Change from baseline in the Investigator Global Assessment (IGA) at week 12. The IGA is a 5-point scale used by the investigator to assess overall acne severity, where 0 equals clear skin (no evidence of acne) and 4 equals severe acne. A negative number change from baseline indicates a reduction in acne severity (improvement).	Baseline, Week 12
Change From Baseline in Overall Disease Severity at Week 12	Change from baseline in overall disease severity at week 12. The overall disease severity was evaluated by the investigator using a 7-point scale to rate the overall acne severity (lesions, inflammation, facial redness and skin condition), where 0=no acne lesions and 6=most severe acne. A negative number change from baseline indicates a reduction in overall acne disease severity (improvement).	Baseline, Week 12
Change From Baseline in Non-Inflammatory Lesion Counts (Open and Closed Comedones) at Week 12	Change from baseline in non-inflammatory lesion counts (open/closed comedones) at week 12. Comedones are small bumps on the skin (lesions) caused by acne and found at the opening of a skin pore. Open comedones (also known as a blackheads) have a microscopic opening to the skin surface, while closed comedones (also known as whiteheads or "pimples") lack the opening to the skin. A negative number change from baseline indicates a reduction in lesion counts (improvement).	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (ACTUAL): August 1, 2009
• Study Completion (ACTUAL): August 1, 2009

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: February 2, 2009
• First Posted (ESTIMATE): February 3, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 31, 2011
• Last Update Submitted That Met QC Criteria: September 22, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Dermatologic Agents; Anti-Bacterial Agents; Leprostatic Agents; Keratolytic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Folic Acid Antagonists; Dapsone; Tretinoin
• Other Study ID Numbers: MA-ACZ0801